High dose corticosteroid pulses in treatment-resistant depression : a randomized double-blind placebo-controlled pilot study - Treating Unresponsive Depression – Overcoming Refractoriness

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006089-40-GB

Enrollment

Registered

2008-03-25

Start date

2007-03-20

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resistant depression MedDRA version: 8.1 Level: LLT Classification code 10012378 Term: Depression

Interventions

Product Name: hydrocortisone Pharmaceutical Form: Intravenous infusion INN or Proposed INN: HYDROCORTISONE CAS Number: 50237 Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients will be aged 21- 75, have DSM-IV major depression and a Montgomery Asberg Depression Score (MADRS) >20. They will not be responding to their current treatment and have failed at least two treatments in the current episode. Patients will be able to give written, informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: History of psychotic symptoms, of reported significant memory impairment, of significant head trauma, of antisocial personality disorder, of alcohol or drug dependence, of hypertension, of duodenal or gastric ulcers, of diabetes, of glaucoma or of cataracts. Current suicidal intent, pregnancy or infection. Past neurosurgery for affective disorders, resistance to ECT, history of mania, resistance to TMS or to Magnetic Stimulation Therapy. Antidepressant medication change within the previous 6 weeks. Patient reports that they have not had chickenpox. Significant abnormalities in baseline physical examination or routine blood tests (FBC, U&E, LFT, TFT, ESR). Abnormal Fasting Blood Glucose. Weight <120Kg, BMI <40.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary hypothesis we aim to test is that three daily pulses of high dose hydrocortisone will produce an immediate mood elevating effect in people with Treatment Resistant Depression that will translate to an antidepressant effect by week 3. ; Secondary Objective: To study whether those patients who did not respond to the first double-blind treatment regime will respond when given an open trial of hydrocortisone similarly given. To study sleep changes during treatment. ;Primary end point(s): Montgomery-Asberg Depression Rating Scale at Day 29	—

Measure

Time frame

Main Objective: The primary hypothesis we aim to test is that three daily pulses of high dose hydrocortisone will produce an immediate mood elevating effect in people with Treatment Resistant Depression that will translate to an antidepressant effect by week 3. ; Secondary Objective: To study whether those patients who did not respond to the first double-blind treatment regime will respond when given an open trial of hydrocortisone similarly given. To study sleep changes during treatment. ;Primary end point(s): Montgomery-Asberg Depression Rating Scale at Day 29

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026